Chapter 7 - Drug Patents

Question 1

Which U.S. department processes and grants all drug patents?

Answer 1

The U.S. Patent and Trademark Office.

Question 2

What must a drug be to be worthy of a patent?

Answer 2

It must have qualities that are novel, useful, and not obvious.

Question 3

What is exclusivity in regards to a patent?

Answer 3

Exclusive marketing rights granted by the FDA upon approval of a drug.

Question 4

What is the duration of exclusivity for an orphan drug?

Answer 4

7 years.

Question 5

How long can a patent be challenged?

Answer 5

180 days.

Question 6

Describe the names given to drugs.

Answer 6

Brand name (marketing purposes) and generic name (chemical or scientific name that describes the active ingredients).

Question 7

ANDA

Answer 7

Abbreviated New Drug Application

Question 8

Hatch-Waxman Act

Answer 8

Drug Price Competition and Patent Term Restoration Act of 1984 - Made it easier to bring generic drugs to the market.

Question 9

Biologic equivalents

Answer 9

Chemical equivalents, which when administered in the same amounts, will provide the same biological or physiological availability as measured by blood and urine levels.

Question 10

Generic substitution

Answer 10

Act of dispensing a different brand (unbranded generic product) for the product described.